Szefler Stanley J, Baker James W, Uryniak Tom, Goldman Mitchell, Silkoff Philip E
Division of Pediatric Clinical Pharmacology and Allergy/Immunology, National Jewish Medical and Research Center, 1400 Jackson Street, Denver, CO 80206, USA.
J Allergy Clin Immunol. 2007 Nov;120(5):1043-50. doi: 10.1016/j.jaci.2007.08.063.
Budesonide inhalation suspension and the leukotriene receptor antagonist montelukast have demonstrated efficacy in children with mild persistent asthma, but comparative long-term studies in young children are needed.
To compare the long-term efficacy and safety of budesonide inhalation suspension and montelukast.
After a run-in period, children 2 to 8 years old with mild asthma or recurrent wheezing were randomized to once-daily budesonide inhalation suspension 0.5 mg or once-daily oral montelukast 4 or 5 mg for 52 weeks. Subjects were stepped up to twice-daily budesonide inhalation suspension or oral corticosteroids for mild or severe asthma worsening, respectively. The primary outcome was time to first additional medication for asthma worsening at 52 weeks. Secondary variables included times to the first additional asthma medication measured at 12 and 26 weeks; times to the first asthma exacerbation (mild and severe) measured at 12, 26, and 52 weeks; exacerbation rates (mild and severe) over a period of 52 weeks; diary variables (eg, peak expiratory flow [PEF]); patient-reported outcomes; and Global Physician and Caregiver Assessments.
No significant between-group differences were observed for time to first additional asthma medication at 52 weeks; however, time to first additional asthma medication was longer (unadjusted P = .050) at 12 weeks and exacerbation rates were lower over a period of 52 weeks (unadjusted P = .034) for budesonide versus montelukast. Time to first severe exacerbation (requiring oral corticosteroids) was similar in both groups, but the percentage of subjects requiring oral corticosteroids over a period of 52 weeks was lower with budesonide (25.5% vs 32.0%). Peak flow and Caregiver and Physician Global Assessments favored budesonide.
Both treatments provided acceptable asthma control; however, overall measures favored budesonide inhalation suspension over montelukast.
These findings are consistent with studies in older children demonstrating better outcomes with inhaled corticosteroids versus montelukast.
布地奈德吸入混悬液和白三烯受体拮抗剂孟鲁司特已证明对轻度持续性哮喘儿童有效，但需要对幼儿进行比较性长期研究。
比较布地奈德吸入混悬液和孟鲁司特的长期疗效和安全性。
在经过导入期后，将2至8岁患有轻度哮喘或反复喘息的儿童随机分为每日一次吸入0.5毫克布地奈德混悬液组或每日一次口服4或5毫克孟鲁司特组，为期52周。对于轻度或重度哮喘恶化的受试者，分别增加至每日两次吸入布地奈德混悬液或口服糖皮质激素。主要结局是在52周时首次因哮喘恶化而使用额外药物的时间。次要变量包括在12周和26周时首次使用额外哮喘药物的时间；在12周、26周和52周时首次哮喘发作（轻度和重度）的时间；52周期间的发作率（轻度和重度）；日记变量（如呼气峰值流速[PEF]）；患者报告的结局；以及全球医生和护理人员评估。
在52周时，首次使用额外哮喘药物的时间在组间未观察到显著差异；然而，在12周时，布地奈德组首次使用额外哮喘药物的时间更长（未调整P = 0.050），且在52周期间发作率更低（未调整P = 0.034）。两组首次严重发作（需要口服糖皮质激素）的时间相似，但在52周期间需要口服糖皮质激素的受试者百分比布地奈德组更低（25.5%对32.0%）。峰值流速以及护理人员和医生的全球评估更倾向于布地奈德。
两种治疗方法均能提供可接受的哮喘控制；然而，总体指标显示布地奈德吸入混悬液优于孟鲁司特。
这些发现与对大龄儿童的研究一致，表明吸入性糖皮质激素比孟鲁司特的效果更好。
